Serum Exosomal miRNA Predicting the Therapeutic Efficiency in Lung Squamous Carcinoma
NCT ID: NCT05854030
Last Updated: 2023-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-04-01
2023-08-31
Brief Summary
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Detailed Description
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We plan to enroll 50 patients with advanced treatment-naïve squamous cell carcinoma and 10 healthy people in the present study. Peripheral blood from the plasma of 10 healthy individuals and 50 pulmonary squamous cell carcinoma (SCC) patients will be collected before first-line treatment and after 2 cycles of anti-PD-L1 immunotherapy combined with chemotherapy.
Firstly, exosomal miRNAs extracted from peripheral blood will be analyzed through high-throughput RNA sequencing to identify specific exosomal miRNAs.
Secondly, through analyzing the PFS and OS follow-up data of patients, they are divided into different subgroups. We explore the value of early predicting efficacy of exosome miRNA basing on sequencing results.
Thirdly, we compared the exo-miRNA biomarker with the value of PD-L1 expression in predicting the efficacy of immunotherapy.
Lastly, we suggest exo-miRNA combined with PD-L1 as a biomarker combination in predicting anti-PD-L1 immunotherapy efficacy to better select the potential benefit population suitable for immunotherapy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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advanced lung squamous carcinoma
advanced pulmonary carcinoma with pathological diagnosis of squamous cell and are applied with first line treatment of anti-PD-L1 combined with chemotherapy
collect plasma samples and clinical features
8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately
normol volunteers
10 normol volunteers will be enrolled in the group
collect plasma samples and clinical features
8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately
Interventions
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collect plasma samples and clinical features
8ml of peripheral blood need to be collected from pre- and post-treatment advanced pulmonary squamous carcinoma separately
Eligibility Criteria
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Inclusion Criteria
2. Patients have not previously received first-line anti-tumor systemic therapy for advanced lung cancer;
3. At least one measurable lesion according to the irRECIST 1.1 standard;
4. Physical condition and organ function allow for systemic antitumor therapy, including standard chemotherapy and immunotherapy;
5. Age ≥ 18 years at the time of signing the informed consent form;
6. Estimated survival≥ 3 months;
7. Patients can follow the planned schedule and actively cooperate in returning to the hospital for regular clinical follow-up and necessary treatment;
8. It can provide the clinical data required for research and is willing to use the test data for further scientific research and commercial product development.
Exclusion Criteria
2. The investigators judged that the patient also had other serious medical conditions that could affect follow-up and short-term survival;
3. Any other medical condition and social/psychological problems which the investigator determines that the patient is not suitable to participate in this study;
4. Contrast-enhanced MRI or contrast-enhanced CT for clinical follow-up is not acceptable;
5. Have an active or previous auto-immune disease that is likely to recur;
6. Other antineoplastic therapies were planned for the duration of the study.
18 Years
ALL
Yes
Sponsors
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Tianjin Chest Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Richeng Richeng, Postdoctor
Role: STUDY_CHAIR
Tianjin Medical University Cancer Institute and Hospital
Locations
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TianjinCIH
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Walsh RJ, Soo RA. Resistance to immune checkpoint inhibitors in non-small cell lung cancer: biomarkers and therapeutic strategies. Ther Adv Med Oncol. 2020 Jul 3;12:1758835920937902. doi: 10.1177/1758835920937902. eCollection 2020.
Hansen AR, Siu LL. PD-L1 Testing in Cancer: Challenges in Companion Diagnostic Development. JAMA Oncol. 2016 Jan;2(1):15-6. doi: 10.1001/jamaoncol.2015.4685. No abstract available.
Sacher AG, Gandhi L. Biomarkers for the Clinical Use of PD-1/PD-L1 Inhibitors in Non-Small-Cell Lung Cancer: A Review. JAMA Oncol. 2016 Sep 1;2(9):1217-22. doi: 10.1001/jamaoncol.2016.0639.
Rizvi NA, Hellmann MD, Snyder A, Kvistborg P, Makarov V, Havel JJ, Lee W, Yuan J, Wong P, Ho TS, Miller ML, Rekhtman N, Moreira AL, Ibrahim F, Bruggeman C, Gasmi B, Zappasodi R, Maeda Y, Sander C, Garon EB, Merghoub T, Wolchok JD, Schumacher TN, Chan TA. Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science. 2015 Apr 3;348(6230):124-8. doi: 10.1126/science.aaa1348. Epub 2015 Mar 12.
Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8.
Yu W, Hurley J, Roberts D, Chakrabortty SK, Enderle D, Noerholm M, Breakefield XO, Skog JK. Exosome-based liquid biopsies in cancer: opportunities and challenges. Ann Oncol. 2021 Apr;32(4):466-477. doi: 10.1016/j.annonc.2021.01.074. Epub 2021 Feb 4.
Mashouri L, Yousefi H, Aref AR, Ahadi AM, Molaei F, Alahari SK. Exosomes: composition, biogenesis, and mechanisms in cancer metastasis and drug resistance. Mol Cancer. 2019 Apr 2;18(1):75. doi: 10.1186/s12943-019-0991-5.
Correction: Correlation of plasma exosomal microRNAs with the efficacy of immunotherapy in EGFR / ALK wild-type advanced non-small cell lung cancer. J Immunother Cancer. 2020 May;8(1):e000376corr1. doi: 10.1136/jitc-2019-000376corr1. No abstract available.
Cazzoli R, Buttitta F, Di Nicola M, Malatesta S, Marchetti A, Rom WN, Pass HI. microRNAs derived from circulating exosomes as noninvasive biomarkers for screening and diagnosing lung cancer. J Thorac Oncol. 2013 Sep;8(9):1156-62. doi: 10.1097/JTO.0b013e318299ac32.
Zhang C, Chong X, Jiang F, Gao J, Chen Y, Jia K, Fan M, Liu X, An J, Li J, Zhang X, Shen L. Plasma extracellular vesicle derived protein profile predicting and monitoring immunotherapeutic outcomes of gastric cancer. J Extracell Vesicles. 2022 Apr;11(4):e12209. doi: 10.1002/jev2.12209.
Cordonnier M, Nardin C, Chanteloup G, Derangere V, Algros MP, Arnould L, Garrido C, Aubin F, Gobbo J. Tracking the evolution of circulating exosomal-PD-L1 to monitor melanoma patients. J Extracell Vesicles. 2020 Jan 7;9(1):1710899. doi: 10.1080/20013078.2019.1710899. eCollection 2020.
Other Identifiers
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SCC-EV-2022
Identifier Type: -
Identifier Source: org_study_id
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